Biostatistician

AlzaSyno Life Sciences; Gurugram District; On-site; INR 1,800,000 - 3,000,000; Full time

Job summary

Alzasyno Life Sciences Pvt Ltd in Gurugram is hiring a Biostatistician with 5-8 years in CRO or pharma to lead statistical activities for clinical trials, SAPs, and protocols.

The ideal candidate will be an expert in SAS programming, CDISC SDTM/ADaM, ICH-GCP, and regulatory submissions, with strong communication and collaboration across Clinical, Data Management, and Medical teams.

Qualifications

• Experience: 5-8 years in a CRO or Pharmaceutical environment.
• Technical Skills: Expert-level SAS programming skills, with proficiency in SAS/R or Python as a plus.
• Regulatory Knowledge: Strong understanding of CDISC (SDTM/ADaM), ICH-GCP, and global regulatory requirements (FDA, EMA).
• Soft Skills: Excellent communication, leadership, and problem-solving abilities with a high attention to detail.

Responsibilities

• Lead the statistical design and analysis for clinical trials, including the development and review of SAPs and protocols.
• Perform sample size calculations, develop randomization schemes, and ensure scientifically sound statistical methodologies.
• Oversee the creation and validation of SDTM and ADaM datasets, ensuring full compliance with CDISC standards.
• Generate, review, and quality control TLFs for clinical study reports and regulatory submissions.
• Manage and support internal and external audits, ensuring all statistical deliverables adhere to ICH-GCP and regulatory guidelines.
• Provide statistical input for regulatory submissions (e.g., IND, NDA) and support responses to health authority queries.
• Collaborate with cross-functional teams including Clinical, Data Management, and Medical teams to ensure seamless project execution.

Skills

SAS programming

SAS/R or Python

CDISC SDTM/ADaM

ICH-GCP

Communication

Leadership

Tools

SAS

R

Python

Job description

Alzasyno Life Sciences Pvt Ltd is #hiring for a Biostatistician to join our team in Gurugram!

We are looking for a skilled professional with 5-8 years of experience in the CRO/Pharma industry to lead statistical activities for our clinical trials. If you have a strong foundation in clinical trial methodology and regulatory standards, we want to hear from you!

Key Responsibilities:

• Lead the statistical design and analysis for clinical trials, including the development and review of Statistical Analysis Plans (SAPs) and protocols.
• Perform sample size calculations, develop randomization schemes, and ensure scientifically sound statistical methodologies.
• Oversee the creation and validation of SDTM and ADaM datasets, ensuring full compliance with CDISC standards.
• Generate, review, and quality control Tables, Listings, and Figures (TLFs) for clinical study reports and regulatory submissions.
• Manage and support internal and external audits, ensuring all statistical deliverables adhere to ICH-GCP and regulatory guidelines.
• Provide statistical input for regulatory submissions (e.g., IND, NDA) and support responses to health authority queries.
• Collaborate with cross-functional teams including Clinical, Data Management, and Medical teams to ensure seamless project execution.

Ideal Candidate Profile:

• Experience: 5-8 years in a CRO or Pharmaceutical environment.
• Technical Skills: Expert-level SAS programming skills, with proficiency in SAS/R or Python as a plus.
• Regulatory Knowledge: Strong understanding of CDISC (SDTM/ADaM), ICH-GCP, and global regulatory requirements (FDA, EMA).
• Soft Skills: Excellent communication, leadership, and problem-solving abilities with a high attention to detail.

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